Manufacturers of hernia mesh implants in the U.S. are required to adhere to certain FDA regulations. This involves maintaining good practices at the facility where the mesh is designed, created, packaged, labeled, etc. It also may mean conducting clinical studies on the safety and effectiveness of the hernia mesh prior to FDA approval, is a predicate device is not available. When the company fails to adhere to regulations, warning letters are sent. Here, we answer a few questions about what these warning letters are and mean.
- 1. What are FDA warnings?
- 2. What warnings did FDA file on hernia mesh products?
- 3. Would clinical studies have made a difference?
- 4. How do warning letters and absence of clinical studies impact your hernia mesh lawsuit?
The FDA will inspect company sites after adverse reports begin to pile up or other action has brought the facility's attention to the agency. If violations are found, warning letters will be sent. FDA warning letters are detailed and specific. In this letter, the agency likely will provide:
- A description of the inspection
- The FDA personnel involved in the inspection or investigation
- Any personnel involved from the company itself
- A summary of the findings
- The specific regulations violated, and
- The action(s) that must be taken in order to correct the violation(s).
Typically, a company has 15 days to respond to the letter. 1 Warning letters are typically one of the FDA's more serious actions to take against a company.
The FDA has issued warnings to several hernia mesh manufacturers. Most notable are the warning letters sent to Atrium regarding its manufacturing facility for C-QUR mesh products. The warning letter dated October 11, 2012, cites manufacturing and sterilization violations and overall quality system violations. 2 One striking issue was the case of hair being found in the hernia mesh C-QUR products -- more than 30 instances reported.
Atrium promised to make corrections, but the FDA claimed the company ignored all warning letters. The FDA filed a complaint and an injunction was placed against Atrium. 3
Clinical studies would have likely or could have made a difference in some cases where the FDA warned the company about its violations if those cases were related to the safety and effectiveness of the hernia mesh product. In the case of Ethicon's Physiomesh, the presence of clinical trials could have made a difference.
Clinical trials are required for medical device products that have the high potential to cause harm to consumers. Clinical trials, however, are not necessary if a similar product is already on the market. For many hernia mesh products, the latter applies -- just as it did in the case of Ethicon's Physiomesh. As such, clinical studies were not required before the Physiomesh was approved for U.S. use.
Clinical studies can provide important data, including
- Data on the safety of the product,
- Data on the product's effectiveness, and -- among other important data --
- Data on the product's failure rate.
Post studies indicate that the Physiomesh has a high failure rate, which generally materializes six months on average after the mesh is implanted in the patient. In fact, the rate was found to be around 20 percent. 4 Mesh failure meant patients had to undergo subsequent surgery. With each surgery, scar tissue builds up, and with more scar tissue, the success of surgery to repair the hernia is less likely. 5
If Ethicon had been required to conduct studies prior to and as a requirement of FDA approval via the Premarket Approval process, then Ethicon could have saved significant hardship, time, and money. As a result of the Physiomesh failure, Ethicon voluntarily recalled the product after studies were completed. 6 In its recall, the company states:
Ethicon is recalling the product following an analysis conducted at the request of the Ethicon Medical Safety Team of unpublished data from two (2) large independent hernia registries (Herniamed German Registry and Danish Hernia Database - DHDB). The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH™ Composite Mesh were higher than the average rate s of the comparator set of meshes among patients in these registries.
Because premarket safety studies were not conducted prior to Physiomesh being placed in the U.S. market, thousands of defective mesh implants were used in hernia repair surgeries. The company is now subject to lawsuits across the country for injuries emanating from the mesh product. Adverse reports filed with the FDA suggest the following injuries were most associated with the Physiomesh:
There is no conclusive answer to the question of what a difference a clinical study would have made if conducted before FDA approved the device. But what we can say is that the data from premarket studies could have alerted Ethicon and the FDA to potential issues. Those issues could have possibly been addressed prior to the product getting out into the market and injuring consumers.
Hernia mesh lawsuits are pending throughout the country. Lawsuits have been and continue to be filed against manufacturers listed above: Atrium and Ethicon, as well as other manufacturers, like Gore, Genzyme, C.R. Bard, and Covidien. Your attorney will use warning letters and clinical studies as part of the investigation and evidence process. The absence of premarket studies is also considered and may be incorporated into the overall argument your attorney makes on your behalf.
If you have been injured by a hernia mesh product, you may be eligible for compensation. Our personal injury and product liability attorneys are actively taking hernia mesh cases. Contact us today to learn more. We will review your case and advise you of your options. Don't wait, you only have so long according to the applicable statute of limitations to file your claim.
- Food and Drug Administration. Warning Letters.
- Food and Drug Administration. Warning Letter to Atrium Medical Corporation, October 11, 2012.
- United States v. Atrium Medical Corporation et al., Case 1:15-cv-00041. Complaint for Permanent Injunction, Doc. 1, Filed 02/03/15.
- Pawlak M., Hilgers R.D., Bury K., Lehmann A., Owczuk R., Śmietański M. Comparison of two different concepts of mesh and fixation technique in laparoscopic ventral hernia repair: a randomized controlled trial. Surg Endosc. 2016 Mar; 30(3):1188-97. doi: 10.1007/s00464-015-4329-0. Epub 2015 Jul 3.
- Ethicon. Urgent: Field Safety Notice. Ethicon PhysiomeshTM Flexible Composite Mesh (All Product Codes) 25 May 2016.